CUNSA, Solution 360 - International health records
Health registrations and regulatory affairs for food supplements
Each country regulates dietary supplements with its own laws: ingredient limits, permitted label claims, and different import requirements. CUNSA addresses this complexity as part of its comprehensive service. We adapt the formula and labeling to the regulations of the target market and provide all the manufacturer’s technical documentation your distributor needs to obtain health registration and import the product.
Why is the regulation of supplements different in each country?
A supplement that is legal in the United States cannot necessarily be imported as is to Mexico, Chile, Peru, or Egypt. Each country defines its own list of permitted ingredients, maximum dosages, product categorization (supplement, food, or drug), and the claims that the label can and cannot display. An unadapted formula may be held up in customs or rejected at the registration checkpoint. Therefore, regulation is not a final step; it is part of the product design process from day one.
How do we divide regulatory roles?
It’s important to be precise about who does what. In most markets, the holder of the sanitary registration is the local importer or distributor—the legal entity authorized by the relevant authority in their country. CUNSA’s role is to provide technical support to the manufacturer: we deliver the adapted formula, compliant labeling, and the documentation required for registration. We work closely with your local team to ensure the dossier is complete and accurate when submitted to the health authority.
Regulatory documentation that we provide
As a manufacturer in the United States, CUNSA provides the supporting documentation required by health authorities for imported products, which typically includes:
- Certificate of Free Sale (CFS) for the product in the U.S.
- GMP certificate for the manufacturing facility.
- Product specifications and technical data sheet.
- Certificate of Analysis (CoA) per batch.
- Qualitative and quantitative formula adapted to the limits of the destination market.
- Label artwork compliant with local labeling regulations.
Formula adaptation and labeling
Before manufacturing, we review your formula against the legislation of the target market: we verify that each ingredient and each dose is permitted, and we adjust as needed. Simultaneously, we adapt the labeling—nutritional declaration, mandatory warnings, and permitted claims—to the format required by each authority. The result is a product that passes registration and customs without any surprises.
FDA and 21 CFR Part 111 Compliance
Our facility operates under the Good Manufacturing Practices for dietary supplements established by the FDA in 21 CFR Part 111. This standard—batch quality control, ingredient traceability, and production documentation—is the foundation upon which all export documentation is built. Manufacturing under U.S. standards gives your distributor a strong foothold with any health authority.
Markets we know
CUNSA exports to markets with diverse regulatory regimes in the Americas, Asia, the Middle East, and Africa. We are familiar with the frameworks of agencies such as COFEPRIS (Mexico), INVIMA (Colombia), DIGEMID (Peru), ISP (Chile), and ARCSA (Ecuador), among others, and we prepare manufacturer documentation tailored to their requirements.
Frequently Asked Questions
CUNSA provides the manufacturer’s technical documentation, along with the adapted formula and label. Registration with the relevant authority is handled by the importer or local distributor, and we support them throughout the entire process.
We detected it in the regulatory review prior to manufacturing and propose a formula adjustment in accordance with local regulations.
Yes. Our plant manufactures under the FDA’s 21 CFR Part 111 Good Manufacturing Practices.
Yes, it is part of the export documentation provided by CUNSA.
